Kornimate/medical-research-clean huggingface dataset:
fabrication of a definitive cad/cam titanium abutment prior to guided surgery: a pilot study.

Conditions: Single Edentulous Space

Summary: the study will involve placing a dental implant through a guided surgery protocol developed using 3d ct technology. because the implant position is planned digitally using the ct data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. in doing so, this makes the protocol for patient care simpler and faster. in fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. the study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. the optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.


Eligibility criteria:
inclusion criteria: * partially edentulous with single edentulous space * edentulous site where previous tooth has been extracted for at least two months * minimum of 20 teeth present * able to tolerate dental implant surgical and restorative procedures * consent to participate in clinical trial exclusion criteria: * asa class 3+ * present drug use * is pregnant or plans to become pregnant * patients in need of lateral window sinus graft * patients in need of grafting prior to implant placement * patients in need of extensive grafting at time of implant placement * tooth is present or extracted within the last 2 months * history of iv bisphosphonate use or oral bisphosphonate use contraindicating dental implant therapy * untreated caries or periodontal disease * severe bruxism * smoker within past 6 months * unlikely to be able to comply with study procedures according to investigators * known allergy to any materials used in dental implant surgery
safety and efficacy of insulin aspart in children with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * treatment with insulin for at least 6 months prior to inclusion * hba1c below or equal to 11.0 % * currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion exclusion criteria: * the receipt of any investigational drug within one month prior to this trial * recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator * total daily insulin doses at least 1.80 iu/kg * treatment with oral hypoglycaemic agents * known or suspected allergy to trial product or related products
a randomized controlled trial to compare the glycemic control, with or without the connected solution, of adult type 2 diabetic participants on basal insulin in taiwan

Conditions: Type 2 Diabetes Mellitus

Summary: the connected solution investigated in this study is the combination of the titration module "insultrate" and a cell phone application (app) named health2sync (h2s) that synchronizes participants' self-monitoring blood glucose data and electronic health records to a platform overseen by their treating physicians. this study investigates if this connected solution helps to improve glycemic control more effectively than physician-recommended routine management (i.e., usual care) in participants with type 2 diabetes mellitus (t2dm).

study duration per participant will be up to 9 months, including a screening period of up to 3 months and a study intervention period of 24 weeks (± 14 days).

Eligibility criteria:
inclusion criteria: * participants must be ≥ 20 years of age at the time of signing the informed consent * participants were diagnosed with t2dm prior to the screening visit * participants who are insulin naïve, or already treated with basal insulin but uncontrolled with the same insulin regimen for at least 3 months (90 days) prior to day 1 * participants with hba1c between 7.5% and 11% (inclusive) at the screening visit and day 1 * participants with fasting self-measured blood glucose (fsmbg) or fasting plasma glucose (fpg) \>130 mg/dl at the screening visit and day 1 * capable of giving signed informed consent * willing and able to use the h2s app and glucometer exclusion criteria: * participants with diabetes other than t2dm * h2s app/ bgm is not appropriate for the participant or use of device is otherwise contraindicated (in the opinion of the investigators) * participants with hypoglycemia unawareness or with severe hypoglycemia within the past 90 days prior to the screening visit and until day 1 * hospitalization (for any reason) in the past 30 days prior to the screening visit and until day 1 * participants with severe conditions/concomitant diseases precluding their safety or ability to participate in this study, as judged by the investigators - participants are not on stable dose of glucose lowering therapy including oads, glucagon-like peptide-1 (glp-1) receptor agonists, or basal insulin therapy within the past 12 weeks prior to the screening visit and until day 1 per investigator's discretion * participants using mealtime insulin for more than 10 days in the last 90 days before the screening visit and until day 1 * participants who used h2s app within 1 month prior to the screening visit and until day 1 randomization * participants who have taken other investigational drugs within 90 days or 5 half-lives prior to screening or randomization, whichever is longer the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
a phase 1 study of ab521 monotherapy and combination therapies in renal cell carcinoma and other solid tumors

Conditions: Clear Cell Renal Cell Carcinoma; Solid Tumors

Summary: the purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccrcc) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab in participants with ccrcc in the dose expansion stage


Eligibility criteria:
key inclusion criteria: * must have at least one measurable lesion per recist guidance * eastern cooperative oncology group (ecog) performance status score of ≤ 1 * disease-specific criteria for dose escalation: * participants may have any pathologically confirmed solid tumor type where no other treatment options are available * creatinine clearance ≥ 40 ml/min disease-specific criteria for dose-expansion: * histologically confirmed ccrcc * creatinine clearance ≥ 40 ml/min key exclusion criteria: * use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product * has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous * history of trauma or major surgery within 28 days prior to the first dose of investigational product * for all expansion cohorts: prior treatment with an hypoxia inducible factor (hif)-2α inhibitor. for the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: clear cell renal cell carcinoma solid tumor malignancies ab521 casdatifan kidney cancer zimberelimab ab122
pain after prp revascularization and endodontic treatment of non-vital mandibular molars with apical periodontitis

Conditions: Postoperative Pain

Summary: randomized clinical trial which evaluate thr post-operative pain following platelet rich plasma (prp) revascularization versus conventional endodontic treatment of non-vital mature mandibular molars with chronic peri-apical periodontitis

it will be done in 2 visits where in the firist visit, i will finish cleaning and shaping of the canals and inject double antibiotic paste as intracanal medication. in the second visit, removal of intracanal medication then obturaton of the canals in the control group. while in the intervention group,over instrumentation of the canals beyond the working length using k-file size 20-35 to establish bleeding in the canals.then blood sample is collected for prp preparation then injected into the canal.the patient will record post operative pain 6,12,24,48 hours then 3,4,5 days later.then they will do cbct at 6, 12 months after the treatment to assess peri-apical healing

Eligibility criteria:
inclusion criteria: * medically free patients, between 18-40 years * patients with necrotic pulp in mandibular molar permanent teeth with closed apex exclusion criteria: * illiterate patient * patients with systemic diseases * pregnant women * patients that have allergy to ciprofloxacin or metronidazole * teeth that: * have vertical root fracture, coronal perforation, and calcification. * re-treatment cases * non restorable * patients that have t.m.j. disorder
a 3-way cross-over study on the effects of qrl-101 on transcranial magnetic stimulation and nerve excitability in healthy participants

Conditions: Healthy

Summary: this is a phase i, prospective, single-center, randomized, double-blind, placebo-controlled, three-way cross-over study to evaluate the safety and tolerability of qrl-101 and investigate the pharmacodynamic effects of two dose levels of qrl-101 on transcranial magnetic stimulation (tms) and nerve excitability threshold tracking (nett) in healthy participants. after screening and training, participants will be randomized to one of six treatment sequences of william's square balanced for first-order carry-over design consisting of two doses of qrl-101 or placebo, with at least seven days between each treatment.


Eligibility criteria:
inclusion criteria: 1. males and postmenopausal women between the ages ≥ 18 and ≤ 55. 2. bmi ≥ 18.0 and ≤ 32.0 kg/m2, and body weight ≥ 50 kg, at screening. 3. willing and able to practice effective contraception from the screening through at least 2 days after their last dose of study treatment. 4. participants must be able to communicate effectively (in dutch) with the study personnel and be willing to comply with the requirements of the study. exclusion criteria: 1. evidence of any acute or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study. 2. history or presence of conditions which, in the judgment of the investigator, are known to interfere with drug absorption, distribution, metabolism, or excretion. 3. history or presence of conditions which might increase the risk of performing tms (e.g., epilepsy, febrile seizures, intracranial mass lesion, hydrocephalus, clinically significant head injury or trauma, metal objects in the brain or skull, cochlear implant or a deep brain stimulation device) 4. any condition that could interfere with the quality of, or ability to perform, tms (e.g., an abnormal sleeping pattern, unremovable dreadlocks or hairpieces, or a resting motor threshold (rmt) of more than 75%. \*other inclusion and exclusion criteria may apply\*

Keywords: qrl-101
patients who have failed first line treatment for locally advanced and/or metastatic cervical cancer

Conditions: Uterine Neoplasms

Summary: primary: * to assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline. secondary: * to assess the safety and tolerability of oxaliplatin * to assess time to progression and overall survival.


Eligibility criteria:
inclusion criteria: * have locally advanced/metastatic squamous or adenocarcinoma of the cervix * prior therapy with cisplatin allowed * first-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy * must have measurable disease * histologically proven carcinoma of the cervix * ecog ps ≤2 * no other serious concomitant illness * fully recovered from any prior therapy * lab: anc \>1500 mm³, platelets \> 100000 mm³, creatinine ≤ 1.5 x normal value, bilirubin ≤ 1.5 x normal value, sgpt (alt) ≤ 2.5 x normal value exclusion criteria: * known allergy to one of the study drugs * peripheral neuropathy \> grade2 the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
toleromune house dust mite (hdm) tolerability study

Conditions: Rhinoconjunctivitis

Summary: house dust mites (hdms) are arachnids that infest bedding, carpet, upholstered furniture and fabric. like many other allergens, exposure to hdma in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. in contrast to other allergens, there is evidence that hdma leads to the development of asthma, in addition to exacerbating pre-existing asthma in hdm-sensitised patients. toleromune house dust mite (tm-hdm), a combination of seven synthetic peptide immuno-regulatory epitopes, is being developed for the treatment of hdm allergy. this study to assess the tolerability of toleromune house dust mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.

a multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of tm-hdm in subjects with controlled asthma and hdm-induced rhinoconjunctivitis.

Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years. * asthma controlled by step 1 or step 2 treatment as defined by gina in the four weeks prior to randomisation. * asthma controlled by step 1 or step 2 treatment as defined by gina in the four weeks prior to randomisation. * no change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation. * a reliable history consistent with rhinoconjunctivitis on exposure to hdm for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation * positive skin prick test to dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control. * immunocap® dermatophagoides pteronyssinus-specific immunoglobulin e ≥ 0.35 ku/l. exclusion criteria: * history of life-threatening asthma * asthma exacerbation in the 12 weeks prior to randomisation * pre-bronchodilator forced expiratory volume in 1 second (fev1) \< 80 % of predicted, regardless of the cause. * post-bronchodilator fev1/forced vital capacity ratio of \< 0.7. * concurrent respiratory disease that would confound study participation or affect subject safety. * non-hdm allergy that may significantly interfere with the results of this study. 7. previous immunotherapy treatment with any hdm allergen for more than 1 month within 5 years prior to screening.

Keywords: hdm allergy rhinoconjunctivitis immunotherapy toleromune hdm
effect of probiotics in myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs)

Conditions: Myalgic Encephalomyelitis; Chronic Fatigue Syndrome

Summary: myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs) is a neurological disease. currently there is no effective treatment for me/cfs due to unclear etiology of the disease. the aim of this randomized double-blind placebo-control clinical trial is to study the efficacy of the probiotic food supplement "gutmagnific™" in me/cfs and comorbid gastrointestinal complications. the outcome of the study will be assessed based on the data from different self-reporting questionnaires and intestinal microbial flora analysis.

myalgic encephalomyelitis/ chronic fatigue syndrome (me/cfs) is a neurological disease with different symptoms such as fatigue. symptoms get worse by physical or mental exertion which usually persists for more than 24 hours (post-exertional malaise, pem). me/cfs is often characterized by reduced functional capacity, worsening social relationships and reduced ability to cope with work or study. the exact cause of the me/cfs is presently unknown however a history of viral infection is common among me/cfs patients. prolonged post viral fatigue can develop into a chronic illness and me/cfs. current research strongly suggests involvement of gastrointestinal tract and gut microflora disturbances in the pathogenesis with strong evidence supporting the role of imbalance of gut microflora, damaged gut barrier functions and dysfunctional immune responses. there are some features shared with gastrointestinal conditions like irritable bowel syndrome (ibs). gutmagnific™ is an evidence-based probiotic food supplement, scientifically designed to be effective in correcting imbalances of the gut microflora, repairing a damaged gut barrier and reducing inflammation. the strain combination in gutmagnific™ has been carefully designed for its efficacy in ibs and therefore it can be reasonably expected to be also effective in me/cfs.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs) at stora sköndals neurological rehabilitation clinic * gastrointestinal complications similar to ibs exclusion criteria: * consumption of any probiotics two weeks before enrolment * consumption of other probiotic products during the trial

Keywords: myalgic encephalomyelitis chronic fatigue syndrome me/cfs post viral fatigue post viral fatigue syndrome fatigue post exertional malaise pem irritable bowel syndrome ibs lactobacillus probiotic gutmagnific
effect of on-tdcs on memory function improvement and related circuits in stable depression patients

Conditions: Depression

Summary: so far, antidepressant drugs have limited memory improvement. transcranial direct current stimulation, as a non-invasive and safe neuroregulatory technique, is a new direction to improve memory.in this study, transcranial direct current stimulation of the greater occipital nerve was used to explore the effect of improving memory function in patients with stable depression, and related studies were conducted on the locus coeruleus-noadrenal loop and the functional connection between locus coeruleus, hippocampus and amygdala.

in this study, a randomized, controlled, double-blind design was adopted. patients with depression were randomly divided into an intervention group and a control group to receive true or fake tdcs stimulation respectively. clinical data, memory and other related cognitive function assessment, eeg, resting state fmri, saliva and blood indicators were collected two weeks before and two weeks after the intervention, and followed up for eight weeks. finally, data correlation analysis was performed.

Eligibility criteria:
inclusion criteria: 1. eligible for icd-10 depressive episode (f32) or recurrent depressive disorder (f33) diagnosis; 2. antidepressant therapy for at least 8 weeks, with no antidepressant adjustment for nearly 2 months 3. hamd-17 scores ≤ 7 points at the time of enrollment; cgi score ≦2; 4. chief complaint of memory impairment, pdq-d score of cognitive impairment ≧17 points; 5. right-handed. exclusion criteria: 1. a history of major physical diseases; 2. have other mental disorders that meet the diagnostic criteria of icd-10; 3. hearing, color blindness, color weakness or receive electroconvulsive therapy; 4. alcohol dependence or substance abuse; 5. patients with intellectual disability; 6. pregnant or lactating women or those planning to become pregnant; 7. patients with contraindications to tdcs.

Keywords: depression transcranial direct current stimulation the locus coeruleus-noradrenergic circuit
a pilot study assessing the effectiveness of use of guided imagery for treatment of pain and symptom management in women with post-mastectomy pain syndrome

Conditions: Pain Syndrome; Pain; Symptom Management

Summary: to learn if using guided imagery and deep breathing techniques can help with pain management in patients who have post-mastectomy pain syndrome.

objectives: primary objective: -to evaluate the effectiveness of use of guided imagery and deep breathing techniques in pain management compared to control arm in patients with post-mastectomy pain syndrome who don't receive intervention and only receive standard care. secondary objective: to evaluate effectiveness of guided imagery and deep breathing techniques in symptom cluster management including fatigue, sleep, depression, and anxiety and in general quality of life compared to control arm who don't receive intervention and only receive standard care.

Eligibility criteria:
inclusion criteria: 1. breast cancer patients who were performed mastectomy in previous 12 months 2. post-mastectomy pain syndrome \>4 weeks. 3. patients who report 2-10 on the baseline pain severity score or 2-10 on the baseline pain interference score 4. patients ≥ 18 years old and ≤ 70 years old 5. must understand and read english, sign a written informed consent, and follow protocol requirements 6. if on medication for anxiety or depression, stable dose of medications for management of anxiety or depression symptoms for at least six weeks prior to enrollment with no plans to change medications in the subsequent four weeks. increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable exclusion criteria: 1. pending surgery during treatment 2. suicidal ideation 3. diagnosis of a formal thought disorder (e.g., schizophrenia)
efficacy of simeox airway clearance therapy in children with cystic fibrosis

Conditions: Cystic Fibrosis in Children; Airway Clearance Impairment

Summary: chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (cf). new airway clearance techniques (acts) adapted to individual needs are still being sought to achieve the best effect of airway clearance. the primary aim of this study is to assess the efficacy of a new act (simeox) on pulmonary function in children with cf. 40 cf patients with stable respiratory function will be randomized 1:1 to simeox or conventional chest physiotherapy (ccpt) therapy (control group) and treated at home during 1 month. after a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.


Eligibility criteria:
inclusion criteria: * subject and his or her legally appointed and authorized representative will agree for treatment with simeox technology * willing and able to cooperate and learn new technic of drainage. * age 8-18 years, on the date of admission to hospital. * confirmed diagnosis of cf as determined by the investigator. * able to perform pulmonary tests exclusion criteria: history of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. this includes, but is not limited to, the following: * contraindications to bronchial chest physiotherapy * hemoptysis * pneumothorax * heart disease * recent chest surgery * recent chest injury * history of lung transplantation

Keywords: airway clearance technique